Hypertension, Medication Non-Adherence
Conditions
Brief summary
This will be a two--arm Randomized controlled trial (RCT) design that will assess efficacy of the Smartphone Medication Adherence Stops Hypertension (SMASH) mobile health ( mHealth) program compared to an enhanced standard care (SC) program. Participants will be African-American (AA) hypertension patients with no other known chronic diseases. Participants found to have uncontrolled hypertension (HTN) and medication non-adherence via electronic device monitoring will be randomized to SMASH or enhanced Standard Care (SC). The SMASH group will receive reminders in the form of auditory and visual reminders from a pill monitoring device when their medication dose is due, they will monitor their blood pressure at home and will receive tailored motivational text messages based upon levels of adherence . Enhanced SC group will use the pill monitoring device without reminder functions enabled and will receive text messages on topics of healthy lifestyles not related to medication adherence and hypertension. The active intervention will continue for 6 months and follow-up will continue for 1 year.
Detailed description
192 AAs (21-59 yrs ) with uncontrolled HTN (no other comorbidities) and Medication Non-Adherence (MNA) will be recruited according to the inclusion and exclusion criteria found elsewhere. In the first phase of screening,resting BP protocols will be performed to determine hypertension is uncontrolled. Only subjects with verified uncontrolled HTN will proceed to the second screening phase .This is a 4 week medication monitoring phase using an electronic medication device with reminder alerts deactivated.Medication non-adherence (MNA) will be determined through medication possession ratio and by the timestamped intake adherence to their predesignated intake schedule across the 4 week period. MA score \<0.85 over the 4-week screening and whose subsequent resting BP evaluations reconfirm uncontrolled HTN will be eligible for enrollment into the RCT. SMASH subjects will have their pill monitor reminder functions activated, start receiving personalized motivational text messages and provided and instructed on use of a validated Bluetooth--enabled BP monitor used at home during the intervention period. Enhanced SC subjects will continue to use the pill device with reminder functions disabled for another 6 months. In order to control for attention exposure SC subjects will be sent text messages on topics related to healthy lifestyle behaviors (diet, physical activity,no smoke exposure) but not related to Medication Adherence (MA) or HTN. All subjects will complete 5 study visits where BP,medication possession ratios, and surveys will be completed. 24-hour Ambulatory Blood Pressure (ABP) monitoring will be performed every 6-months (4 times) during the study.
Interventions
BEHAVIORALSMASH
Auditory and visual reminders are active on Pill device will alert subject each time their medication dose is due. Pill device will transmit dose taken time stamps to researchers. Text message the following morning with tailored motivational messages that reflect the medication dose adherence from the preceding day. Subjects will monitor their BP at home at least every third day using Bluetooth monitor linked to smartphone to transmit encrypted readings to researchers.
BEHAVIORALEnhanced SC
Auditory and visual reminders are inactive on Pill device. Pill device will transmit dose taken times to researchers. Healthy lifestyle test messages as attention control.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
1. African American or Black, 21--59 years old 2. Prescribed medication(s) only for HTN 3. Medication possession ratio (MPR) \<.85 for last 3 months 4. uncontrolled HTN (SBP ≥130 mmHg) based upon last clinic visit within previous 12 months, initial clinic screening & subsequent baseline recruitment evaluation following one month med intake screening with score of \<.85 5. 24--hour SBP ≥ 130 mmHg on clinic screening and subsequent recruitment evaluation 6. Ability to speak, hear and understand English 7. Able to take their own BP and self--administer medications 8. Owns smart phone with data plan 9. Primary care provider's assent that patient is able to participate
Exclusion criteria
1. No other known chronic disease (e.g., chronic kidney disease (GFR\<50 mL/1.7 m2/min;; diabetes (type one or two) renal dialysis cancer diagnosis or treatment in past 2 years prior cv event such as heart attack, congestive heart failure, arterial stent, coronary artery bypass graft psychiatric illness 2. Beck Depression Inventory score \>13 3. Ongoing substance abuse (e.g., \>21 drinks/week) 4. Planned pregnancy 5. Vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Meeting JNC8 Guidelines for BP Control | at 6 months at the end of intervention | Percent of subjects meeting JNC8 Guidelines for BP control (\<140/90) |
| Percent of Participants* With Medication Adherence to >.90 as Accurate and Appropriate | Average across 6 mos.of intervention | Medication adherence \>.90 using electronic medication intake devices. An algorithm is used which takes into account timing of dosage intakes using timestamped data from the devices. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Autonomous Motivation | Months 3,6 of intervention period and at months 6 and 12 of follow-up period. | Changes in Autonomous Motivation Questionnaire with increase in Relative Autonomy Index desired. (Attached)(Range -36 to 36) |
| Changes in Medication Adherence Self-Efficacy | Months 1 and 6 | Changes in Medication Adherence Self-Efficacy (MASES-R) with increased self-efficacy (higher scores) desired. (attached) (Range: 1-4) |
| Percent of Subjects Achieving and Maintaining Medication Adherence >.90. | Months 3,6 of intervention period and at months 6 and 12 of follow-up period. | Percent of subjects achieving and maintaining Medication Adherence \>.90. |
| Percent of Subject Achieving and Maintaining JNC8 Guidelines for BP Control (<140/90) | Month 6 of intervention and months 6 and 12 of follow-up period | Percent of subject achieving and maintaining JNC8 Guidelines for BP control (\<140/90) |
| Percent Achieving and Sustaining 24-hr BP Control (< 130/80 mmHg) | Month 6 of intervention period and at month 6 and 12 of follow-up period. | 24-hr ABP BP average SBP to (\< 130/80 mmHg) - 0 participants with this data reported. Our technology team changed half way through the trial and our ability to use the 24 hour ambulatory monitors code that was built within our institution and transfer it to use with the external data team was unsuccessful. |
Countries
United States
Participant flow
Pre-assignment details
We will use 8 practice sites in each arm RCT design with clinic as unit of randomization and patient as unit of analysis.
Participants by arm
| Arm | Count |
|---|---|
| SMASH Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring
SMASH: Auditory and visual reminders are active on Pill device will alert subject each time their medication dose is due. Pill device will transmit dose taken time stamps to researchers. Text message the following morning with tailored motivational messages that reflect the medication dose adherence from the preceding day. Subjects will monitor their BP at home at least every third day using Bluetooth monitor linked to smartphone to transmit encrypted readings to researchers. | 97 |
| Enhanced SC No reminder functions on the pill monitoring device, attention control text messages
Enhanced SC: Auditory and visual reminders are inactive on Pill device. Pill device will transmit dose taken times to researchers. Healthy lifestyle test messages as attention control. | 107 |
| Total | 204 |
Baseline characteristics
| Characteristic | SMASH | Enhanced SC | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 97 Participants | 107 Participants | 204 Participants |
| Age, Continuous | 50.0 years STANDARD_DEVIATION 9.3 | 47.0 years STANDARD_DEVIATION 9.7 | 48.4 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants | 107 Participants | 204 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 97 Participants | 107 Participants | 204 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 97 participants | 107 participants | 204 participants |
| Sex: Female, Male Female | 65 Participants | 74 Participants | 139 Participants |
| Sex: Female, Male Male | 32 Participants | 33 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 107 |
| other Total, other adverse events | 0 / 97 | 0 / 107 |
| serious Total, serious adverse events | 0 / 97 | 0 / 107 |
Outcome results
Primary
Percent of Participants* With Medication Adherence to >.90 as Accurate and Appropriate
Medication adherence \>.90 using electronic medication intake devices. An algorithm is used which takes into account timing of dosage intakes using timestamped data from the devices.
Time frame: Average across 6 mos.of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SMASH | Percent of Participants* With Medication Adherence to >.90 as Accurate and Appropriate | 27.5 percentage of participants | Standard Deviation 29.4 |
| Enhanced SC | Percent of Participants* With Medication Adherence to >.90 as Accurate and Appropriate | 80.3 percentage of participants | Standard Deviation 9.5 |
Primary
Percent of Subjects Meeting JNC8 Guidelines for BP Control
Percent of subjects meeting JNC8 Guidelines for BP control (\<140/90)
Time frame: at 6 months at the end of intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SMASH | Percent of Subjects Meeting JNC8 Guidelines for BP Control | 97 Participants |
| Enhanced SC | Percent of Subjects Meeting JNC8 Guidelines for BP Control | 106 Participants |
Secondary
Changes in Autonomous Motivation
Changes in Autonomous Motivation Questionnaire with increase in Relative Autonomy Index desired. (Attached)(Range -36 to 36)
Time frame: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.
Secondary
Changes in Medication Adherence Self-Efficacy
Changes in Medication Adherence Self-Efficacy (MASES-R) with increased self-efficacy (higher scores) desired. (attached) (Range: 1-4)
Time frame: Months 1 and 6
Secondary
Percent Achieving and Sustaining 24-hr BP Control (< 130/80 mmHg)
24-hr ABP BP average SBP to (\< 130/80 mmHg) - 0 participants with this data reported. Our technology team changed half way through the trial and our ability to use the 24 hour ambulatory monitors code that was built within our institution and transfer it to use with the external data team was unsuccessful.
Time frame: Month 6 of intervention period and at month 6 and 12 of follow-up period.
Secondary
Percent of Subject Achieving and Maintaining JNC8 Guidelines for BP Control (<140/90)
Percent of subject achieving and maintaining JNC8 Guidelines for BP control (\<140/90)
Time frame: Month 6 of intervention and months 6 and 12 of follow-up period
Secondary
Percent of Subjects Achieving and Maintaining Medication Adherence >.90.
Percent of subjects achieving and maintaining Medication Adherence \>.90.
Time frame: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.